Regulatory Flexibilities Help Ease EU Amoxicillin Shortages
The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.
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New French Body To Lead Efforts Against Drug Shortages
A new committee including representatives of the French pharma industry, health professionals and patients is to lay the groundwork for a longer-term approach to preventing and managing medicine supply chain issues. A separate initiative launched by the prime minister will look at medicines access issues and strengthening the French manufacturing base.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
EU Commission Again Delays Pharma Revision Proposals, Citing ‘Busy Agenda’
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.